How the H1N1 Scare Prepared Biotech for COVID-19

Albert Schmelzer has spent nearly two decades researching and working on the development of manufacturing for antibodies at MedImmune, now integrated into AstraZeneca, and he vividly remembers the challenges the United States faced during the height of the H1N1 swine flu outbreak in 2009. One of the major obstacles was producing enough vaccine doses to combat the virus, an effort Schmelzer said was undermined by a lack of collaboration within the biotechnology industry and coordination through US government partners.  

"Everyone was scrambling to include the new strains [of the virus] in their vaccines, and each company was coming up with its own approach to do that," said Schmelzer, a member of Northwestern Engineering's Master of Biotechnology program (MBP) Industrial Advisory Board (IAB). "Was it really essential to have everybody working independently on solutions, or was there a better way through a pre-competitive approach that could get us to a public good sooner?" 

More than a decade later, Schmelzer, who is a director of cell culture and fermentation sciences at AstraZeneca, said the industry learned from that scramble when it came time to manufacture vaccines and monoclonal antibodies for COVID-19. For example, Merck, a competitor of Johnson & Johnson, helped produce and package the Johnson & Johnson vaccine, while Sanofi partnered to produce increased amounts of the Pfizer vaccine.

"The idea of two private companies that are generally competing against each other working together to make more products for people is amazing. That's great because it helps everyone," Schmelzer said. "The question is: can we do that for future pandemic programs instead of all trying to fight for the same contract manufacturers? Can we use our own internal manufacturing capacities that might be sitting idle to help some other company that has a great product but maybe not the capital to book a manufacturing site at risk?" 

Those are two of the countless COVID-19-related questions Schmelzer has asked since the outset of the pandemic. As a Chemistry, Manufacturing, and Control (CMC) team lead at AstraZeneca, Schmelzer is responsible for all bioprocess development activities for the company's COVID-19 therapeutic antibody program. He also serves as an upstream functional lead that allows him to help execute day-to-day experiments to make sure the company's work is satisfying programmatic commitments to the organization and the US government.

One of the greatest challenges he faces in those roles is the fluidity that comes as more knowledge is gained about COVID-19. Even though the pandemic is more than one year old, Schmelzer said the majority of people don't truly understand the complexity of the virus and how easily it transmits and mutates. He also sees a dual-sided dilemma: people wanted a vaccine as soon as possible, but there is a broad swath of vaccine hesitancy because of how quickly solutions were developed and the false narrative that safety considerations were ignored.  

"There is still a perception that corners were cut to accelerate the development, and, therefore, some of these drugs may be less safe than they should be," he said. "Having consistent messaging from the government and thought-leaders, and having reassurances from health agencies such as the FDA that no corners were cut, will help people appreciate what we've been able to do and be more confident in what we have." 

Consistent communication is a key for combatting vaccine hesitancy, Schmelzer said, and that is why the Industrial Advisory Board recommends MBP place such a strong emphasis on messaging for their students. One reason Schmelzer enjoys being affiliated with MBP is because the program builds its curriculum off of the insights and broad experience and knowledge of the IAB. That means that MBP graduates leave the program ready to take on vital obstacles facing the industry and make a difference immediately.

"Quite a few MBP alumni have progressed well within their careers, and that is a reflection on the quality of students that come in, as well as the rigor of the program to push students to think broadly and use research opportunities and cooperative opportunities in addition to the classwork," Schmelzer said. "I've seen students that are part of other programs that don't have those elements, and the speed with which they're able to contribute and grow is not necessarily the same as the MBP students." 

For those considering MBP, Schmelzer suggested "taking the plunge."

"I know the upfront investments look steep, but the value you get at the end far outweighs the upfront cost," he said. "The connections we have, the quality of the staff, and the quality of the program will provide a huge springboard to your professional career."